Data Capture Design & Development
CRF and data capture design, database specifications, edit checks, validated builds, UAT, go-live support, amendments, and change control.
CONNECTED DATA. PRACTICAL DECISIONS.
Better data starts with better thinking.
We bring a connected view of clinical data to the study team, giving Clinical Operations earlier, more specific insight and practical recommendations. The result is stronger RBQM execution, cleaner data sooner, and less avoidable burden for sites and CRAs.
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OUR SERVICES
Connected support from database design through analysis.
Clinical Data Management
Study planning, data cleaning, medical coding, cross-domain review, query management, reconciliation, reporting, database lock, and archival.
Vendor Selection & Management
We support vendor evaluation and selection, implementation, testing, and ongoing management across clinical data providers. Our centralized view helps connect vendor activities with Clinical Operations, the clinical database, and downstream data needs.
External Data & Integrations
Data transfer specifications, transfer testing, vendor coordination, integration oversight, ongoing reconciliation, and final data review. Our centralized view across external data sources helps us support Clinical Operations by connecting issues across vendors, sites, and the clinical database.
Biostatistics
Study design consultation, sample size and power calculations, SAP development, endpoint and estimand definition, interim analyses, DSMB support, and final analysis.
Statistical Programming
SDTM and ADaM datasets, tables, listings and figures, SAS and R programming, safety outputs, ad hoc analyses, CDISC support, QC, and submission deliverables.
COMPLEX & PIVOTAL STUDIES
Complex studies need experienced judgment.
As studies become larger or more complex, good execution depends on knowing where to focus. We combine experienced study leadership with practical support across data management, biostatistics, programming, and external data oversight.
We adjust resourcing, review, automation, and oversight based on the protocol, endpoints, data volume, timelines, and actual study risk rather than forcing every study into the same delivery model.
Global & multisite executionStudy processes designed to support distributed teams and complex operational models.
High-volume data reviewStructured review, metrics, and automation to keep data cleaning focused and predictable.
Interim & DSMB readinessCoordinated data cuts, reconciliation, statistical outputs, and review support.
Lock & analysis readinessClear ownership from ongoing cleaning through final reconciliation, database lock, and analysis.
THE DATAFY DIFFERENCE
A broader view of the study.
Data Management sits at the intersection of sites, vendors, safety, statistics, and the clinical database. We use that perspective to spot connections, anticipate downstream impact, and help Clinical Operations move issues toward resolution. We provide independent data oversight while working as an integrated part of the study team.
Experienced People Stay Involved
Senior team members remain actively involved throughout the engagement, bringing continuity and study knowledge from planning through delivery.
Solutions That Move the Study Forward
We identify what needs attention, assess the impact, and bring forward a practical path to resolution.
Part of the Study Team
We work closely with Clinical Operations, Statistics, Safety, vendors, and sites rather than operating in a data management silo.
Decisions Grounded in Study Expertise
We understand the protocol, endpoints, data flow, and downstream analysis so recommendations reflect the study as a whole and the downstream impact of each decision.
DELIVERY THAT HOLDS UP
100%
track record of database go-live before first patient / first visit.
The right solution for the study.
We tailor the approach to the study, focusing process and oversight where they add value. We look at the protocol, the data, the risk, and the downstream impact, then recommend an approach that makes sense for the study.
QUALITY & DATA GOVERNANCE
Traceable processes. Clear ownership. Inspection-ready thinking.
Data Governance
Defined ownership, traceability, controlled processes, and documented review across the clinical data lifecycle.
Vendor Oversight
Structured management of external data specifications, testing, reconciliation, issue resolution, and final delivery.
Audit-Tested QMS
Our quality management system has been tested through client audits and supports controlled procedures, training, validation, change management, and documented quality review.
Data Integrity
Review approaches designed to support complete, consistent, attributable, and analysis-ready clinical data.
A FORWARD APPROACH
Smarter approaches where they matter.
We use technology, automation, and process improvement where they meaningfully improve quality, visibility, or efficiency. We focus innovation where it simplifies the work or meaningfully improves the result.
Smarter Study Design
We look beyond specifications to improve data collection, review workflows, and downstream usability before problems become embedded in the study.
Useful Visibility
Metrics and reporting are designed to show what needs attention and support action, not simply generate more reporting.
Connected Data
We connect information across external vendors, systems, and the clinical database to improve oversight and identify issues earlier.
Practical Automation
We automate repeatable data checks and review steps where it improves consistency, speeds identification of issues, and keeps experienced teams focused on judgment.
HOW WE WORK
Study expertise. Stronger execution.
EDC DESIGN
Designing for cleaner data collection
We design with the study in mind. We identify opportunities to simplify data entry, reduce redundancy, and improve downstream cleaning while preserving the data needed to support study endpoints.
EXTERNAL DATA
Managing the path across systems
We connect the full external data lifecycle. We bring together specifications, testing, transfers, reconciliation, and clinical database impact across central labs, imaging, ECG, IRT, eCOA/ClinRO, and other specialty data providers.
DATA TO ANALYSIS
Aligning collection with the analysis
We connect Data Management, Biostatistics, and Programming early so analysis requirements inform decisions throughout the study and avoidable downstream rework is reduced.
ABOUT DATAFY CLINICAL
Experienced people. Hands-on partnership.
Datafy Clinical was founded in 2019 by experienced clinical data management leaders who had already spent years working together. We built Datafy around a straightforward idea: experienced people should stay close to the work, understand the study, and have the autonomy to solve problems.
Today, our team brings experience across clinical data management, data capture design and development, biostatistics, statistical programming, and external data. We work as an extension of sponsor teams, bringing study knowledge, practical judgment, and a connected view across functions.
WHAT OUR CLIENTS SAY
Trusted by clinical teams.
READY TO MOVE FORWARD?